A trial looking at cabazitaxel for cancer of the penis that has come back after treatment (JAVA-P)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Penile cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at a chemotherapy drug called cabazitaxel for cancer of the penis. It is for men whose cancer has spread into surrounding tissue (is locally advanced), or to another part of the body and has come back after treatment.

More about this trial

If cancer of the penis is locally advanced or has spread to another part of the body, doctors can use chemotherapy to treat it. But sometimes the cancer can start to grow again. So doctors are trying to improve treatment for men in this situation.

In this trial, researchers are looking at a chemotherapy drug called cabazitaxel (also known as Jevtana). The aims of the study are find out

If cabazitaxel helps men with cancer of the penis

More about the side effects and how it affects quality of life

Who can enter

You may be able to join this trial if all of the following apply.

You have squamous cell cancer of the penis that has grown into surrounding tissues or lymph nodes, or has spread to another part of the body and has come back after treatment

You have had chemotherapy that included either cisplatin and fluorouracil (also called 5FU) or a drug combination called TPF (this includes the drugs docetaxel, cisplation and fluorouracil)

Have an infection and you are having antibiotic or antifungal treatment

Have a medical condition such as diabetes that is not controlled with medication

Have had high blood pressure that isn’t well controlled with medication

Are having treatment with drugs such as ketoconazole, itraconazole or clarithromycin (you may be able to take part in the trial if you stop taking this, but it is important that you don’t stop any other treatment before discussing it with your doctor)

Have had a stroke, heart attack or unstable heart pain (angina) in the last 6 months

Have any other serious heart problem

Have any other cancer

Have taken part in another clinical trial in the last month

Have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial

Are known to be very sensitive to docetaxel

Are planning on having the yellow fever vaccine

Trial design

Everyone taking part will have cabazitaxel. You have 3 week cycles of treatment. You have cabazitaxel as a drip into a vein once every 3 weeks. It takes about an hour each time. As long as you don’t have bad side effects and your cancer doesn’t get worse, you have up to 6 cycles of treatment in total. This will take about 18 weeks.

The trial team will ask everyone taking part to complete some questionnaires before treatment starts and then regularly throughout treatment. These are called quality of life questionnaires. They look at how the treatment affects you physically and emotionally.

Hospital visits

You see the doctor to have some tests before taking part in the trial. These include

You visit hospital once every 3 weeks to have treatment. You also go to the hospital before each chemotherapy treatment to discuss any side effects with your doctor and have some blood tests.

As you are having cabazitaxel, you have injections with a growth factor drug after each treatment. Growth factors stimulate the bone marrow to make certain blood cells. In this trial you have G-CSF. This is to reduce the chance of infections. You don’t need to go to hospital for this. You or a friend or relative can be taught to give the injection. Or a nurse can visit you at home to give you this drug.

You have a CT scan every 6 weeks until you finish treatment. You see the trial team about 4 weeks after you finish treatment. You will then see them every 3 months for a year. And for a final visit a year after that.

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